NCT02530268

Brief Summary

This prospective, non-interventional, research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for PsA-SpA in a cohort of patients cared for by rheumatologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
907mo left

Started Mar 2013

Longer than P75 for all trials

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Mar 2013Dec 2100

Study Start

First participant enrolled

March 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
85.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2100

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2100

Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

87.8 years

First QC Date

May 1, 2015

Last Update Submit

February 5, 2026

Conditions

Keywords

psoriatic arthritisspondyloarthritisdisease registry

Outcome Measures

Primary Outcomes (1)

  • The major clinical outcomes include an assessment of the epidemiology of Spondyloarthritis; to better understand the presentation, natural history, management and outcomes.

    A minimum of 10 years from last patient enrolled

Study Arms (2)

Ankylosing Spondylitis

Pts presenting to enrolling sites across the US are invited to enroll if eligible

Psoriatic Arthritis

Pts presenting to enrolling sites across the US are invited to enroll if eligible

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are enrolled in the Psoriatic Arthritis and Spondyloarthritis Registry during regularly scheduled office visits. Selected rheumatologists are invited to participate as investigators in the Registry.

You may not qualify if:

  • The patient must be:
  • One of the following:
  • Diagnosed with psoriatic arthritis (PsA) and initiating (prescribed or starting) an eligible medication† for the treatment of PsA at the enrollment visit.
  • Meet the ASAS criteria for axial spondyloarthritis (AxSpA), including radiographic or non-radiographic, and initiating (prescribed or starting) an eligible biologic for the treatment of AxSpA at the enrollment visit.
  • Meet the modified New York classification criteria for ankylosing spondylitis (AS) and initiating (prescribed or starting) an eligible biologic for the treatment of AS at the enrollment visit
  • At least 18 years of age or older
  • Able and willing to provide written consent
  • The patient must not be:
  • Diagnosed with rheumatoid arthritis, systemic lupus erythematosus, or any other form of autoimmune inflammatory arthritis.
  • Participating in or planning to participate in a clinical trial with an interventional research study of a non-marketed or marketed investigational drug (e.g. phase I-IV clinical drug trial, post marketing study or registry study where drug is being provided). Of note, concurrent participation in another observational registry study is not excluded. ∆
  • Once clinical trial participation has ended, a patient is permitted to enroll in the registry if they satisfy the eligibility requirements at the time of enrollment. If the patient participated in the PsA-SpA registry and was exited to join a clinical trial, the patient cannot be re-enrolled in the PsA-SpA registry after clinical trial participation has ended.
  • Patients switching from an originator biologic to a biosimilar satisfy the enrollment eligibility requirement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Mease PJ, Blachley T, Malatestinic WN, Harrold LR, Dube B, Lisse JR, Bolce RJ, Hunter TM. Effectiveness of bDMARDs in ankylosing spondylitis patients by biologic use: experience from the CorEvitas PsA/SpA Registry. Curr Med Res Opin. 2024 Feb;40(2):315-323. doi: 10.1080/03007995.2023.2291160. Epub 2024 Jan 24.

  • Mease PJ, Ogdie A, Tesser J, Shiff NJ, Lin I, Chakravarty SD, Kelleman M, Dodge R, McLean RR, Broadwell A, Kavanaugh A, Merola JF. Six-Month Persistence and Multi-domain Effectiveness of Guselkumab in Adults with Psoriatic Arthritis: Real-World Data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. Rheumatol Ther. 2023 Dec;10(6):1479-1501. doi: 10.1007/s40744-023-00582-w. Epub 2023 Aug 19.

  • Mease PJ, Accortt NA, Rebello S, Etzel CJ, Harrison RW, Aras GA, Gharaibeh MMF, Greenberg JD, Collier DH. Persistence of tumor necrosis factor inhibitor or conventional synthetic disease-modifying antirheumatic drug monotherapy or combination therapy in psoriatic arthritis in a real-world setting. Rheumatol Int. 2019 Sep;39(9):1547-1558. doi: 10.1007/s00296-019-04345-1. Epub 2019 Jul 18.

Related Links

MeSH Terms

Conditions

Arthritis, PsoriaticSpondylarthritis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jeffrey Greenberg, MD, MPH

    CorEvitas

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2015

First Posted

August 21, 2015

Study Start

March 1, 2013

Primary Completion (Estimated)

December 1, 2100

Study Completion (Estimated)

December 1, 2100

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share